Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03659045 |
| Other study ID # |
2017-53 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2019 |
| Est. completion date |
April 4, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In 2016, medical termination of pregnancy represent 64% of total abortions in France. Thus,
it is a frequent act involving a large majority of women and a health-care public subject.
The two medicines used in medical abortion are mifepristone and misoprostol. The efficacy of
mifepristone-misoprostol combination is very high, greater than 90% up to 7 SA. Medical
abortion may be performed in outpatient basis or in short-terme hospitalization. One of the
limits of this technique development is the pain caused by the drugs intake mainly due to the
uterine contractions induced by misoprostol intake. Thus it is recommended a systematic
analgesics intake but despite these guidelines, pain level reported by the patients remains
significant. There is very limited data on the misoprostol influence or mifepristone dose on
pain. In a recent observational multicenter study, mifepristone 600 mg was reported to be
associated with decreased pain compared with mifepristone 200 mg.
In this context, it is important to confirm by a higher level evidence of study that the
protocol using mifepristone 600 mg decreases the pain level of medical abortion compared to a
protocol using mifepristone 200 mg. In the absence of benefit, we will not be able to
conclude to a benefit on the prevention of pain with a protocol associating 600 mg of
mifepristone and 400 μg of misoprostol. If the benefit on pain is confirmed, it will be
interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg dose in terms of
quality of care or medical and economic impact.
The clinical study is interventional, prospective, comparative, randomized, double-blind,
multi-center, conducted in 11 French hospitals carrying out voluntary medical termination of
pregnancy.
The data will be collected by the physician during the 4 consultations (initial consultation
of abortion request, inclusion consultation with Mifegyne® intake, consultation of
misoprostol intake (short-terme hospitalization), follow-up consultation from the available
data in the patient's medical file and from the questionning and clinical examination data
made during these 4 consultations.
Description:
Background and purpose of the study: In 2015, the voluntary interruption of medication
pregnancy represented 57% of the total number of abortions in metropolitan France, ie 116,000
annual acts. Thus, it is a frequent act involving a very large majority of women and a
subject of public health. The two molecules used in drug-induced abortion are mifepristone
and misoprostol. The efficacy of mifepristone-misoprostol combination is very high, greater
than 90% before 7 SA. One of the limits of the diffusion of this technique is the pain caused
by the drug intake mainly at the time of the uterine contractions induced by the taking of
misoprostol. Thus it is recommended a systematic taking of analgesics but despite these
recommendations the level of pain reported by the patients remains high. There is very little
data on the influence of the dose of misoprotol or mifepristone on pain. In a recent
multicenter observational study, mifepristone 600 mg was reported to be associated with a
decrease in pain compared with 200 mg while the misoprostol dose had no influence.
In this context, it is important to confirm by a higher level of evidence study whether the
protocol using 600 mg mifepristone decreases the pain level of drug-induced abortion compared
to a protocol using 200 mg, at the same dose of misoprostol .
MATERIAL AND METHODS: A prospective, randomized, double-blind, multi-center clinical study,
conducted in metropolitan France, in 11 hospital centers performing drug-induced abortion
involving 320 patients. The inclusion criteria will be patients requesting a drug-induced
abortion, agreeing to participate in the study and not having a contraindication to both
study drugs. The main criterion will be the pain felt within 5 hours after taking
misoprostol. The secondary criteria will be the pain felt and painkillers consumed during the
various stages of drug induced abortion, the failure rate, the number of intermediate
consultations, tolerance and quality of life.
Expected results and consequences: In the absence of benefit, the investigators will not be
able to conclude to a benefit on the prevention of the pain with a protocol associating 600
mg of mifepristone and 400 μg of misoprostol. In the event of confirmation of benefit on
pain, it will be interesting to evaluate the efficacy / pain ratio of the 200 mg and 600 mg
dose in terms of the quality of care or the medical and economic impact.
